Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Legal Change Beckons After EU Active Substance Master File Pilot Success

Executive Summary

A voluntary pilot that allowed EU regulators to share their assessments of active substance master files (ASMFs) has been a success. Efforts are now underway to change the EU legislation to establish the ASMF as a stand-alone document in order to permit such work sharing on a mandatory basis.


Related Content

Generics Industry Flags Up 'Duplication' And 'Redundancies' In EU Regulatory Systems
Generic drug makers invited to trial international approval pathway
EMA issues additional guidance on active substance master file procedure





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts